Effects of Obesity on Pharmacokinetics of the Levonorgestrel Emergency Contraceptive Pill
NCT ID: NCT02104609
Last Updated: 2019-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
26 participants
OBSERVATIONAL
2013-04-30
2016-05-31
Brief Summary
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Primary hypothesis:
1\) Obese users of LNG-EC have a pharmacokinetic profile that is consistent with a larger volume of distribution of LNG.
Secondary hypothesis:
1. Alterations in these pharmacokinetic parameters of the LNG-EC regimen in obese women affect the primary mechanism of action, which is inhibition of ovulation.
2. Obesity may affect other factors that alter levels of LNG, such as sex-hormone binding globulin (SHBG) and albumin, which bind LNG and potentially lowers the amount of free LNG.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Normal weight women
Levonorgestrel 1.5mg by mouth once
Levonorgestrel 1.5mg by mouth once
Levonorgestrel 1.5mg by mouth given on menstrual cycle day 8
Obese women
Levonorgestrel 1.5mg by mouth once
Levonorgestrel 1.5mg by mouth once
Levonorgestrel 1.5mg by mouth given on menstrual cycle day 8
Extremely obese women
Levonorgestrel 1.5mg by mouth once
Levonorgestrel 1.5mg by mouth once
Levonorgestrel 1.5mg by mouth given on menstrual cycle day 8
Interventions
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Levonorgestrel 1.5mg by mouth once
Levonorgestrel 1.5mg by mouth given on menstrual cycle day 8
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Regular menstrual cycles (24-35 days) for the past 2 months
* Ovulatory at defined by midluteal progesterone level \>3 ng/mL (Day 18-25)
* Belongs to one of the following categories: normal weight (BMI = 18.5-24.9 kg/m2), obese (BMI = 30-39.9 kg/m2) or extremely obese (BMI ≥ 40 kg/m2)
* Participant has no intention of or desire to conceive (e.g., active attempt to become pregnant or in vitro fertilization) for the duration of the study
* Participant agrees to consistently use an effective method of nonhormonal contraception throughout the duration of study, which could include: condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, non-hormonal intra-uterine devise (IUD), or sterilization.
* Able to give informed consent
Exclusion Criteria
* Known pituitary disorder
* Known adrenal disorder
* Known thyroid disorder
* Use of medication known to alter the cytochrome P450 system
* Use of depot-medroxyprogesterone acetate in the previous 6 months or any other hormonal contraceptive in the previous 3 months
* Currently breastfeeding
* Pregnant
* Pregnancy in the prior month
* Known allergy to medication
* Other specific contraindications to LNG EC
18 Years
35 Years
FEMALE
Yes
Sponsors
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Society of Family Planning
OTHER
University of Southern California
OTHER
Responsible Party
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Melissa Natavio
Asst. Professor
Principal Investigators
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M Natavio
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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University of Southern California
Los Angeles, California, United States
Countries
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Other Identifiers
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HS-12-00602
Identifier Type: -
Identifier Source: org_study_id
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